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BIOSIMILAR APPROVALS

Skylar Jeremias is the Managing Editor for The Center for Biosimilars and The American Journal of Managed Care (AJMC).

Articles

New Danish registry data confirm the safety of switching to infliximab biosimilars, showing low rates of serious adverse events in patients with inflammatory arthritis.

Danish Registry Analysis Finds Consistent Safety After Switching to Infliximab Biosimilar GP1111

A new study confirms KM118, a proposed biosimilar to pertuzumab, shows pharmacokinetic similarity and safety, paving the way for affordable HER2-positive breast cancer treatments.

Early Evidence Supports KM118 as a Biosimilar to Reference Pertuzumab

The US biosimilar market evolves with 90 approvals, significant price drops, and new PBM models enhancing access to cost-effective therapies.

Milestone Approvals, Evolving PBM Models May Redefine the 2026 Biosimilar Landscape

Alex Keeton serves as the executive director of the Biosimilars Council.

FDA Draft Guidance on Biosimilars Is a Win for Patients; Now Congress Must Finish the Job

The Center for Biosimilars connects professionals with insights on biosimilars, health economics, regulatory outcomes, and emerging treatment paradigms.

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1.5 Credits / Gynecologic Cancer, Health Equity, Diversity & Inclusion, Oncology, Women's Health

Advancing Immunotherapy in Endometrial Cancer: A Managed Care Perspective on Personalized Care

Leveraging Managed Care to Optimize Patient Outcomes: Integrating Novel Treatments in Schizophrenia

1.0 Credit / General Pharmacy, Health Equity, Diversity & Inclusion, Law 

Payment for Pharmacist Services: 2025 Update

1.0 Credit / Immunology, Neurology, Rare Diseases

Optimizing Outcomes in Myasthenia Gravis: Therapeutic Advances and Value-Based Care Models

Tyruko, the first natalizumab biosimilar for multiple sclerosis, promises significant savings and competition in the US market.

First Natalizumab Biosimilar Tyruko Launches, Expanding Access in Multiple Sclerosis

UK neurologists release new guidelines for JC virus testing in patients using the natalizumab biosimilar Tyruko, addressing safety and monitoring challenges.

UK Experts Publish Guidance on JC Virus Testing for Natalizumab Biosimilar Tyruko

The FDA designates 2 biosimilars as interchangeable, enhancing access to treatments for inflammatory diseases and multiple sclerosis, while 2 other companies expand their biosimilar partnership to include more products.

Eye on Pharma: Interchangeability Labels and Expanded Biosimilar Partnerships 

Successfully integrating biosimilars into practices requires careful planning and execution, as they impact virtually all aspects of a practice.

Integrating Biosimilars Into Retina and Neurology Practices Requires Careful Planning

The phase 3 trial (NCT04966338) found that a biosimilar ocrelizumab candidate (Xacrel) was equivalent to Ocrevus in reducing the annualized relapse rate and showed comparable safety and efficacy in treating relapsing multiple sclerosis over 96 weeks.

Ocrelizumab Biosimilar Shows Equivalent Efficacy as Multiple Sclerosis Treatment

Dr Prerakkumar Parikh talks about recent FDA approvals for ms biosimilars and the first tocilizumab biosimilar

Dr Prerakkumar Parikh Reacts to FDA Approvals for First Neurology, Tocilizumab Biosimilars

Prerakkumar Parikh, PharmD, director of specialty clinical solutions at Magellan Rx Management, gives insight into the growing world of biosimilars and the role formulary placement plays in biosimilar adoption.

In the second half of 2023, the FDA approved the first 

, which is also the first neurology and first biosimilar indicated for multiple sclerosis, as well as the first 

. Additionally, the FDA approved the first 

From a PBM's perspective, what was your reaction to the FDA approvals of the first MS biosimilar and the first tocilizumab biosimilar?

Yeah, [these are] exciting times as more biosimilars are flowing to the market, especially for newer categories like multiple sclerosis. I'm pretty sure we will see some market shifts happening in that category. Interesting, both [the natalizumab and tocilizumab products] are under the medical benefit right now. So, I think it will probably follow the same success stories of the oncology biosimilars.

Can you explain the role of formulary placement and tiering by PBMs and how these decisions affect the cost-sharing burden for patients who choose biosimilars over reference biologics?

Absolutely. The tiering for some of the biosimilars that have came out are on the specialty tier. So far on the on the pharmacy benefit side, we are seeing the adalimumab biosimilar on that specialty tier along with the brand name product, Humira. So, what that will do is it will allow for access. At the same time, if you have a low-WAC [wholesale acquisition cost] biosimilar at the same level as Humira and if a patient is paying a percentage co-insurance on that specialty tier, a low-WAC biosimilar is going to reduce that cost for the patient as well.

Videos

Prerakkumar Parikh, PharmD, director of specialty clinical solutions at Magellan Rx Management, reacts to recent FDA approvals for the first natalizumab and tocilizumab biosimilars.

Conference

Brian Biehn from Cencora makes predictions for the US biosimilar market based on recent FDA approvals

Cencora's Brian Biehn Forecasts Big Changes for the US Biosimilar Space

Brian Biehn, senior director of biosimilar commercialization at Cencora, formerly known as AmerisourceBergen, recaps some of the major regulatory updates for biosimilars in the United States and makes predictions for how the market will develop in the years to come.

2023 was a big year for biosimilars in the US, with the market introductions of 8 adalimumab biosimilars as well as regulatory approvals for the first biosimilar tocilizumab, nataliuzmab, and subcutaneous infliximab. How do you think these advancements will shape the biosimilar market in the coming years?

Yeah, 2023 was definitely a big year for biosimilars. As you mentioned, we continue to have really good momentum with approvals. The approvals are written into new molecules such as tocilizumab and natalizumab. The approval for natalizumab [marks] the first neurological biosimilar, which is expected to hit the market in 2024. All eyes are still on adalimumab, though, and the Humira biosimilars.

So, today we have 9 manufacturers that have [approvals and 8 launches for] biosimilars to Humira [reference adalimumab]. There are still a few in the pipeline. We do believe the success of the future market is going to be shaped by the Humira market, specifically for the pharmacy benefit space [overall] and those biosimilars to come. So they're all kind of looking at Humira and seeing how are those manufacturers going to do? How successful are they going to be? What is the adoption going to look like?

To date, we've seen slow uptake of those Humira biosimilars, but we are expecting that to become more widespread going into 2024 and 2025. We believe there's kind of a period here where [pharmacy benefit managers] and payers need to become comfortable with the Humira products; they need to put them on the formulary. Also, from a downstream perspective, customers and patients need to become more comfortable with these products. So, even though it's been a slow start for Humira [biosimilars] and that's probably the biggest thing that happened in 2023 with those [launches], we do see some upside and are expecting more adoption to occur in the coming years.

Now that ophthalmology biosimilars have been on the market for a year and both FDA-approved products now have interchangeability, what is the current status of ophthalmology biosimilars and how to do you see this changing going forward?

Ophthalmology biosimilars are doing well. We've seen month over month the adoption continues to increase. We do anticipate that this trend is going to continue as there are still more manufacturers in the pipeline, specifically for the Lucentis [ranibizumab] biosimilars, which already have the 2 biosimilars on the market.

We're also really interested to see where the Eylea [aflibercept] market goes. We're expecting, potentially in 2024, biosimilars will start to move in that market. We have some ongoing patent litigation occurring right now that could push that launch back to later, but the most optimistic right now is potentially 2024.

One of the things that we continue to talk about with ophthalmology biosimilars—we've talked about in the past and it's important to most of the biosimilar market categories, but more specifically this one—is education. We've heard that there has been confusion amongst providers and patients with these products, not being aware that they're available, being a little bit hesitant to use them because it is an injection into the eye. So, education still remains to be the largest barrier. We have seen that education gap tighten. As I've said, the adoption has increased over time, but I still think it's important for us as an industry to keep pushing that education forward and trying to combat any misinformation that's going on and drive awareness of these products.

Brian Biehn, senior director of biosimilar commercialization at Cencora, makes predictions for how big regulatory approvals in 2023 will shape the biosimilar space going forward.

Fran Gregory, PharmD, MBA, vice president of emerging therapies at Cardinal Health, explains the importance behind the FDA approval of Tyruko (natalizumab-sztn), the first neurology biosimilar and the first multiple sclerosis (MS) biosimilar to receive regulatory approval in the United States.

Tyruko was developed by Polpharma Biologics and will be marketed globally by Sandoz. The approval marks the fourth FDA approval for a biosimilar in 2023, following 

 (adalimumab-aaty), the autoinjector version of 

 (pegfilgrastim-cbqv), and the high-concentration version of 

What was your reaction to the FDA approval of the first neurology biosimilar, Tyruko, and why is this approval so important?

This is a really exciting approval. We have not had an approval in the neurology space [before]. This is a natalizumab biosimilar for relapsing forms of multiple sclerosis. It is extremely exciting because MS is such a debilitating disease. It's a very, very difficult disease to treat. These patients have many unmet needs, still, even with the number of treatments on the market today. There's still no perfect treatment for these patients.

So again, adding choices so that those patients can have more opportunity to potentially have a better experience with the biosimilar [or] maybe they see direct cost savings from the biosimilar. But I do think that choice [and] competition open the market to more treatment options for physicians and more options for patients as well.

This biosimilar is extremely big news. I know there's so much focus on the adalimumab biosimilars right now but introducing a brand new therapeutic area, with neurology and a biosimilar, is very, very exciting. And I'm really excited that the manufacturer [will be] able to bring this product to market and get FDA approval for this product. I'm really looking forward to it coming to market and providing more options for patients.

Fran Gregory, PharmD, MBA, vice president of emerging therapies at Cardinal Health, shares her reaction to the FDA approval of Tyruko (natalizumab-sztn), the first biosimilar approved to treat multiple sclerosis (MS).

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